Kornimate/medical-research-clean huggingface dataset:
extending ketamine's effects in ocd with exposure and response prevention (ex/rp)

Conditions: Obsessive-Compulsive Disorder

Summary: this study investigates if a single dose of iv ketamine can rapidly improve obsessive-compulsive disorder (ocd) symptoms and whether these effect can be maintained with a condensed course of a type of cognitive behavioral therapy called exposure and response prevention (ex/rp). you will be compensated for your time and travel. participants must be between the ages of 18-55.


Eligibility criteria:
inclusion criteria: * age 18-55 * physically healthy and not currently pregnant * primary diagnosis of ocd * sufficient severity of symptoms * currently off all psychotropic medication or * currently on adequate dose of medication for treatment of ocd, but have not achieved at least partial remission * able to provide consent exclusion criteria: * psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance dependence \[including nicotine\]) * female patients who are either pregnant or nursing * planning to commence ex/rp during the period of the study or those who have completed an adequate dose of ex/rp (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment. period of the study * allergy to ketamine * participants for whom being off of medication is not clinically recommended * medical conditions that make participation unsafe (e.g. high blood pressure, head injury) * currently on medications that make participation unsafe

Keywords: ocd
open versus robotic retromuscular ventral hernia repair

Conditions: Ventral Hernia

Summary: the purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.

all patients presenting to the greenville health system hernia center who meet the inclusion criteria will be considered for enrollment. patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.

Eligibility criteria:
inclusion criteria: * ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm. * at least one of the following risk factors: body mass index \> 30, chronic obstructive pulmonary disease, diabetes mellitus, current smoker (within 1 month) exclusion criteria: * current abdominal wall infection * presence of ileostomy, colostomy, or ileal conduit * center for disease control wound class 3 or 4 * hernia defect \ 15 cm * pregnant women

Keywords: hernia repair robotic hernia repair open hernia repair incisional hernia
pmcf study for profemur® am femoral components and procotyl® o ha coated acetabular components

Conditions: Joint Disease

Summary: microport orthopedics (mpo) is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of its total hip arthroplasty (tha) and resurfacing components marketed in the european union (eu). these types of studies are required by regulatory authorities for all tha and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with the medial device directives (meddev) 2.12/2 rev 2.


Eligibility criteria:
inclusion criteria: subject has undergone primary tha for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; or * correction of functional deformity * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments exclusion criteria: * subjects skeletally immature (less than 21 years of age) at time of primary tha surgery * subjects implanted with non-mpo components (femoral stem, femoral head, acetabular liners) in the enrolled tha * subjects currently enrolled in another clinical study which could affect the endpoints of this protocol * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or having pending incarceration

Keywords: osteoarthritis avascular necrosis correction of functional deformity painful hip dysplasia protrusio acetabuli rheumatoid arthritis ankylosis
dose finding study for retarded phosphatidylcholine in pancolitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to find the optimal dose of retarded release phosphatidylcholine in the most severe form of ulcerative colitis. the hypothesis is that ulcerative colitis (uc) is caused by a barrier dysfunction of the colonic mucus layer. the background of the study is the finding, that the phosphatidylcholine (pc) content of the colonic mucus is strongly reduced in uc compared to healthy controls and patients with crohn´s disease. the content was meuasured in non-inflamed areas of the colon in uc. thus, we evaluate whether a substitution of colonic pc is an effective method.

design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine. population: 10 patients per dose group (6 doses) - 60 patients remark: this includes to historic groups from another study inclusion criteria: ulcerative pancolitis with chronic active course and a clinical index (rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. no systemic steroids or immunosuppressants since 4 weeks. exclusion criteria: pregnancy \& fulminant course

Eligibility criteria:
inclusion criteria: * chronic active ulcerative pancolitis * course more than 4 months * clinical index rachmilewitz 7 or more * endoskopic index 7 or more exclusion criteria: * steroids in the last 4 weeks * immunosuppressants in the last 4 weeks * use of topical klymsa * pregnancy * fulminant course * infectious colitis

Keywords: ulcerative colitis dose finding phosphatidylcholine
utility of lung clearance index score as a noninvasive marker of deployment lung disease

Conditions: Bronchiolitis; Pneumonitis; Dyspnea

Summary: the purpose of this study is to learn more about new noninvasive ways of detecting lung disease in us military personnel and people who worked as contractors during military operations in iraq and afghanistan. this study is looking at conducting a type of breathing test called the lung clearance index (lci) test which is being investigated as a potential noninvasive way to detect the type of lung disease that may be seen in symptomatic deployers retuning from iraq and afghanistan.

the healthy control group will comprise volunteers who are at least 18 years of age, have no history of pre-existing lung disease, and report no respiratory illness in the four weeks preceding enrollment. the symptomatic deployers who have undergone lung biopsy and meet the case definition for deployment-related lung disease. a case of deployment-related lung disease is defined as the presence of unexplained chest symptoms in a deployer who, on a surgical lung biopsy, is found to have bronchiolitis or granulomatous pneumonitis without other known cause.

Eligibility criteria:
inclusion criteria: for the deployer group: * presence of respiratory symptoms (cough, chest tightness, wheezing, shortness of breath or decreased exercise tolerance) following deployment * history of deployment for operation iraqi freedom, operation enduring freedom or operation new dawn for greater than or equal to 6 weeks as either military personnel or a civilian contractor * prior vats biopsy-proven histologic abnormalities of small airways disease. for the control group: * no history of pre-existing lung disease * no respiratory illness in the four weeks preceding enrollment exclusion criteria: for the deployer group: * if on clinical evaluation they were found to have asthma, vocal cord dysfunction or other explanations for their respiratory symptoms and did not need to undergo surgical lung biopsy for diagnosis. * unable to provide informed consent * pregnant subjects for the control group: * pre-existing lung disease * unable to provide informed consent * pregnant subjects
effects of salmon fishmeal ex vivo (fishmeal ex vivo)

Conditions: Metabolic Disease; Inflammation; Endocrine; Obesity

Summary: diabetes contributes significantly to the burden of disease in norway and cardiovascular disease is the main cause of mortality. both lean and fatty fish are shown to have beneficial health effects. in addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin d, vitamin b12, iodine, selenium and more unspecified components such as bioactive peptides. with the expected growth in the aquaculture sector, more protein-rich by-products will become available. the overall aim of this project is to investigate physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation. the investigators will include healthy subjects to a randomized controlled cross over study. the subjects will receive a single, oral dose of fishmeal or whey. blood samples are taken before (fasting) and 30 and 60 minutes after intake. the molecular effects of fishmeal and whey are investigated ex vivo. this is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.


Eligibility criteria:
inclusion criteria: * body mass index 18.5-24.9 kg/m2 exclusion criteria: * body mass index \ 24.9 kg/m2 * known diabetes or high blood pressure * pregnancy or breast feeding * allergy or intolerance to dairy or fish/fish protein.
evaluation of quality of life after orthognathic surgery in a cleft lip and palate context

Conditions: Palate, Cleft

Summary: the purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. this is done through two validated questionnaires: ohip-14 (oral health impact profile) and oqlq (orthognathic quality of life questionnaire) improving the quality of life is the goal of any functional treatment. the demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.


Eligibility criteria:
inclusion criteria: * man and woman ; age: adolescents (12-17 years) and adults; specific medical conditions: cleft lip and palate, malocclusion * non-opposition of the patient * patient willing to comply with all procedures of the study and its duration exclusion criteria * cancellation of orthognathic surgery * impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire
a pilot study of the neural correlates of treatment effect on nicotine craving

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to gather pilot data to determine feasibility of and guide the development of a larger clinical trial investigating the effects of topiramate as an adjunct to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. it is hypothesized that topiramate will decrease nicotine craving and result in improved outcomes for smoking cessation.


Eligibility criteria:
inclusion criteria: * male, between ages of 18-55 * meets dsm-iv criteria for nicotine dependence * smoke at least 20 cigarettes per day * motivated to quit smoking exclusion criteria: * serious or unstable medical conditions * current psychiatric disorder requiring medication or treatment * taking medication that create risk of interaction with study drug * current participation in another smoking cessation treatment
safety and efficacy of tearx xa factor direct inhibitor versus enoxaparin as a venous thromboembolic events (vte) prevention following total knee replacement

Conditions: Total Knee Replacement

Summary: to evaluate influence of therapy on the following efficacy and safety parameters in different tearx dose groups and enoxaparin group: * total venous thromboembolic events (vte), which includes confirmed deep venous thrombosis (dvt), nonfatal pulmonary embolism (pe), and total mortality * incidence of dvt (total, proximal, distal) * incidence of nonfatal pe * incidence of symptomatic vte (dvt, pe) * vte caused mortality * non-vte caused mortality * incidence of all hemorrhagic complications * incidence of major and clinically relevant non-major bleeding * adverse events (aes) and serious adverse events (saes) from subject complaints, physical examination, vital signs, laboratory results


Eligibility criteria:
inclusion criteria: * male or female, age ≥ 18 years; * planned total knee replacement surgery; * signed informed consent form; * willing to comply with the protocol; * willing to use adequate contraception during the trial. exclusion criteria: * surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing * history of venous thrombosis of any location or pe * history of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis * history of evident coagulopathy or in a relative * congenital thrombophilia * bleeding within 6 months of screening; increased risk of bleeding * bmi less than 18,5 or more than 40 kg/m2 * systolic bp \> 180 mmhg and/or diastolic bp \> 110 mmhg registered twice within 15-30 minutes * hb ≤ 10.5 g/dl in female or ≤ 11.5 g/dl in male * platelets \< 100 000/mm3 * clinical significant abnormalities of aptt and/or inr * gfr \< 30 ml/min/1.73 m2 * alt or ast ≥ 2 x uln or total bilirubin ≥1,5 x uln
effect of music on stress and delivery

Conditions: Stress; Delivery Problem for Fetus

Summary: the purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaires, respectively. secondary outcomes to be examined are obstetric and perinatal outcomes

for centuries, music has been known to have therapeutic effects on the body and the mind a large body of findings is related to the therapeutic potential of music in clinical settings, mainly among patients undergoing surgical and dental procedures, and also in other medical environments, such as intensive care, psychiatry, and geriatrics. using music interventions in clinical settings was associated with reductions in negative effects in addition to objective stress and anxiety indices such as reduced heart rate, blood pressure, myocardial oxygen consumption, gastrointestinal function, anxiety, pain, and increased oxytocin levels. one study found that women who listened to music before a cesarean section had a significant increase in positive emotions and a significant reduction in systolic blood pressure compared with a significant increase in diastolic blood pressure and respiratory rate in the control group. li and dong concluded in a different study, that preoperative music intervention can reduce anxiety and pain in women undergoing cesarean delivery. various studies examined the relation of music during labor to pain relief. one study found that the group of women going through music therapy had significantly lower pain, anxiety and a higher finger temperature during the latent phase of labor. one randomly assigned study found that women listened to soft music starting early in the active phase of labor had decreased sensation and distress of active labor pain. to date, no study examined the level of salivary cortisol while music is played at delivery room as an objective estimation of the stress level. in addition to that, there is a lack of information regarding the effect of music during labor on the obstetric and perinatal outcomes. therefore, the purpose of this study is to randomize women to be exposed during labor to different genres of music and study the effect of each genre on the level of objective and subjective stress as manifested by salivary cortisol and personal stress questionnaire, respectively. secondary outcomes to be examined are obstetric and perinatal outcomes.

Eligibility criteria:
inclusion criteria: * age 18-45 * single embryo * term labor, \>=37 weeks of gestation exclusion criteria: * multiple embryos * antepartum fetal death * preterm delivery
the effect of mouth closure on airflow in osa

Conditions: Hypopnea, Sleep

Summary: mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (osa) severity. it is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. however, we propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). the present study investigates the role of mouth breathing as an essential route in some osa patients and its association with upper airway anatomical factors. participants underwent drug-induced sleep endoscopy (dise) with simultaneous pneumotach airflow measurements through the nose and mouth separately. during the dise procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing. we evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. we also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.


Eligibility criteria:
inclusion criteria: * diagnosed obstructive sleep apnea (ahi \> 5 events/h). * scheduled to undergo clinical drug-induced sleep endoscopy. exclusion criteria: * pregnancy * age under 18 years * poor general health * allergy to propofol or dexmedetomidine * history of surgical treatment for sleep apnea, such as palate, tongue base, or epiglottis surgery.

Keywords: obstructive sleep apnea mouth breathing upper airway drug-induced sleep endoscopy
beluga - clinical observations of automatic algorithms for cardiac pacing

Conditions: Bradycardia; Sick Sinus Syndrome; Heart Block

Summary: this study shall evaluate in daily medical practice the clinical results of the av delay hysteresis search algorithm in patients with a insignia ultra or avt pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. in addition use and outcome of automatic functions will be evaluated.


Eligibility criteria:
inclusion criteria: * dual chamber pacemaker (insignia ultra or avt pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, age ≥ 18 years, signed patient information. exclusion criteria: * indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent avb (avb 2/1 and complete), pr \> 250 ms, implant of the device older than 60 days before the inclusion date, heart transplant foreseen within six months, unexplained syncope.
can fentanyl lead to opioid-induced hyperalgesia in healthy volunteers?

Conditions: Healthy

Summary: the purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (nrs) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. pain modalities tested will include transdermal electrical stimulation and cold pressor pain. the investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the nrs.


Eligibility criteria:
inclusion criteria: * healthy (asa i-ii) male volunteers * age \> 18 years * bmi 18 - 25 kg/m2 exclusion criteria: * volunteers unable to give written informed consent * known drug allergies or intolerance to fentanyl * known drug allergies or intolerance to morphine and other opiates * recreational drug addiction or abuse * opiate use in the last month * volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month * history of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease * patients with renal failure (clearance \< 30 ml/min) * obstructive sleep apnea syndrome (osas) * indication for rapid sequence induction * patients not understanding german, french, italian or english

Keywords: opioid induced hyperalgesia fentanyl
an in vitro evaluation of antimicrobial photodynamic therapy on deciduous carious dentin

Conditions: Dental Caries

Summary: despite of the decline of dental caries, this disease is still common in polarized groups affecting children. therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1. control - chlorhexidine and resin modified glass ionomer cement (rmgic); 2. ledtb - antimicrobial photodynamic therapy (apdt) with led (light emission diode) associated with toluidine blue orto dye solution and rmgic; 3. lmb - apdt with laser associated with methylene blue dye solution and rmgic. the patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments. the carious dentin was collected before and after each treatment and the number of streptococcus mutans, streptococcus sobrinus, lactobacillus casei, fusobacterium nucleatum, atopobium rimae and total bacteria were established by quantitative pcr.


Eligibility criteria:
inclusion criteria: * inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. they should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits. exclusion criteria: * children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

Keywords: photochemotherapy bacteria